Variability In Sterility Test Processes And The Benefits Of Modular Workstations

By James Drinkwater, Bioquell UK Process & Compliance Director

This paper reviews some of the current operational practices that incorporate sterility testing and provides an insight into the role of hydrogen peroxide vapor bio-decontamination and continuous particle monitoring.

As requirements for biological contamination control to reduce risks become more understood, the trend is away from ‘open barrier’ systems. Uni-directional flow (UDF-LAF) clean-air benches or biological safety cabinets still have some open exposure to gowned operators that are known to generate biological contamination. Also associated manual disinfection processes, that have variable efficacy and are highly operator dependent, require risk management with respect to potential for false positive sterility test results.